UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000037810 |
|---|---|
| Receipt number | R000043054 |
| Scientific Title | The evaluation study of dopamine transporter and tau protein in elderly-onset depression using positron emission tomography |
| Date of disclosure of the study information | 2019/08/28 |
| Last modified on | 2023/08/31 15:15:09 |
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Basic information
Public title
The evaluation study of dopamine transporter and tau protein in elderly-onset depression using positron emission tomography
Acronym
DAT-TAU study for geriatric depression
Scientific Title
The evaluation study of dopamine transporter and tau protein in elderly-onset depression using positron emission tomography
Scientific Title:Acronym
DAT-TAU study for geriatric depression
Region
| Japan |
Condition
Condition
geriatric depression
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
evaluation of the relationship between dopamine transporter and tau protein in geriatric depression
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Tau protein accumulation in brain and dopamine transporter binding potential in geriatric depression, and their changes over time.
Key secondary outcomes
Evaluation of higher brain function by neuropsychological tests
Degree of atrophy by head MRI
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Device,equipment |
Interventions/Control_1
The subjects are treated with antidepressant drugs in accordance with the Japan Depression Society Treatment Guidelines.
PET 11C PBB3 555MBq
PET 18F FE-PE2I 185MBq
MRI
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 60 | years-old | <= |
Age-upper limit
| 90 | years-old | > |
Gender
Male and Female
Key inclusion criteria
- Subjects who are over 60 years old when obtaining consent
- Subjects diagnosed with F3 by ICD-10 diagnostic criteria
- Subjects who have received sufficient explanation for participation in this study, who can fully understand the subject and can obtain written consent based on his / her free will
Key exclusion criteria
- with past or current history of serious medical illness and/or brain organic diseases
- subject who is contraindicated for the use of MRI
- with past or current history ofsevere liver disease, kidney disease, heart disease, allergy, or severe drug allergy
- pregnant women at the time of the research and those who are likely to become pregnant
- subject who are judged as not suitable for participation in this study
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Yoshiro |
| Middle name | |
| Last name | Okubo |
Organization
Nippon Medical School
Division name
Department of Neuropsychiatry
Zip code
113-8602
Address
1-1-5 Sendagi, Bunkyo-ku, Tokyo, 113-8603, Japan
TEL
+81-3-3822-2131
okubo-y@nms.ac.jp
Public contact
Name of contact person
| 1st name | Takeshi |
| Middle name | |
| Last name | Sakayori |
Organization
Nippon Medical School
Division name
Department of Neuropsychiatry
Zip code
113-8602
Address
1-1-5 Sendagi, Bunkyo-ku, Tokyo, 113-8603, Japan
TEL
+81-3-3822-2131
Homepage URL
sakayori-t@nms.ac.jp
Sponsor or person
Institute
Nippon Medical School
Institute
Department
Personal name
Funding Source
Organization
Japan Society for the Promotion of Science
Organization
Division
Category of Funding Organization
Government offices of other countries
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Nippon Medical School center for clinical research
Address
1-1-5 Sendagi, Bunkyo-ku, Tokyo, 113-8603, Japan
Tel
+81-3-5802-8115
clinicaltrial@nms.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 08 | Month | 28 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Enrolling by invitation
Date of protocol fixation
| 2019 | Year | 08 | Month | 02 | Day |
Date of IRB
| 2019 | Year | 08 | Month | 02 | Day |
Anticipated trial start date
| 2019 | Year | 08 | Month | 26 | Day |
Last follow-up date
| 2024 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2024 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2019 | Year | 08 | Month | 27 | Day |
Last modified on
| 2023 | Year | 08 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043054
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
